Monthly Archives: June 2009

EPA Lists 44 Hazardous Coal Ash Sites

The Environmental Protection Agency has issued a statement concerning the potential hazards of 44 coal ash sites around the country that could pose lethal consequences for nearby residents.
Heightened attention has been given to the coal ash sites after one such site in Tennessee flooded last year. The coal ash sites contain hazardous materials including arsenic, selenium, cadmium, lead and mercury. The EPA plans to inspect the sites to determine if they are structurally sound.
“The high hazard potential means there will be probable loss of human life if there is a significant dam failure,” said Matt Hale, director of EPA’s office of research, conservation and recovery. “It is a measure of what would happen if the dam would fail. It is not a measure of the stability of the dam.”
Coal ash, a by-product of coal burning plants, is stored in ponds or dams. The 44 cited in the EPA report are considered dangerous because of their close proximity to homes. A leak or flood could cause catastrophic damage, including the loss of life.
Coal ash dump sites had not been previously made public due to national security issues.
The sites listed in the EPA report are as follows:
The 10 states, the number of sites, and communities are:
_North Carolina, 12 (Belmont, Walnut Cove, Spencer, Eden, Mount Holy, Terrell and Arden).
_Arizona, 9 (Cochise, Joseph City).
_Kentucky, 7 (Louisa, Harrodsburg, Ghent and Louisville).
_Ohio, 6 (Waterford, Brilliant and Cheshire).
_West Virginia, 4 (Willow Island, St. Albans, Moundsville, New Haven).
_Illiniois, 2 (Havana, Alton).
_Indiana, 1 (Lawrenceburg).
_Pennsylvania, 1 (Shippingport).
_Georgia, 1 (Milledgeville).
_Montana, 1 (Colstrip).

FDA Will Take Another Look at Safety of Bisphenol A

In a move lauded by consumer safety advocates, the FDA will reassess the safety of the highly controversial chemical found in many plastic products from baby bottles to drinking containers.
The FDA decision comes in the wake of a letter sent by Democratic lawmakers serving on the House Energy and Commerce Committee.
Bisphenol-A has been used for the past 60 years to make plastics hard and shatter-proof. It’s also been known to seep into the contents of the plastic containers. Bishpenol A has been linked to cancer, diabetes, developmental damage, as well as heart disease in animals.
According to the CDC, the toxin has been found in the urine samples of 90% of those tested. Recently, 6 of the country’s baby bottle manufacturers have announced they’ll phase out use of the controversial chemical in production of their plastics.
The FDA has been under fire for relying too heavily on industry information about Bisphenol A which has defended use of the product in plastics production.
According to the new FDA chief Margaret Hamburg, the review should be completed by the end of the summer.

FDA Seizes Generics from Caraco Pharmaceuticals

Federal authorities swooped down on Caraco Pharmaceuticals Detroit plant seizing between $15-20 million worth of generic drugs. The drugs were seized after the FDA determined that the generic drugs did not meet standard quality requirements concerning their manufacturing. Among the drugs seized were generic tablets for pain, heart problems, and psychiatric issues.
This is not the first mention of manufacturing problems for the Detroit-based company. Since January, Caraco Pharmaceuticals has been issuing recalls of its generic drugs due to manufacturing problems including oversize tablets.
According to Detroit News, “In response to the seizure, the company said in a statement that it believes “corrective actions have been made and continual improvements are in progress.”
Caraco, which replicates brand name drugs with expired patents, sells about 3.6 billion tablets annually to wholesalers, drug distributors and retail giants.
Its drug lineup, which includes more than 50 generic products, spans everything from prescription treatments for gout to anti-depressants and anti-allergenics.
Caraco has taken some steps to remedy production problems, CEO Daniel Movens said in a company release issued last month. In January, it changed manufacturing and quality control leadership, the company said. It reiterated those comments in its Thursday release.”

FDA: Medical Device Registration a Daunting Task

Given all the issues confronting an overworked and underfunded federal agency such as the FDA, the mammoth project of registering medical devices is at best a daunting task. So says Jay Crowley CDRH senior advisor for patient safety and head of FDA’s unique device identification (UDI) initiatives. Crowley is quoted in the Gray Sheet, “At 50,000 feet, unique device identification is very simple. We could get it done tomorrow, we could get it out there, we could get UDI on medical devices,” says Jay Crowley, CDRH senior advisor for patient safety and head of FDA’s unique device identification (UDI) initiatives.
“But if it’s not implemented, if it doesn’t work its way through the supply chain, through distributors, into hospitals, to that point of patient encounter – we haven’t done anything.”
However, other countries have devised and implemented such a system. That’s not to say it would be easy but in terms of patient safety and medical device information and effectiveness, it’s well worth the effort.
Such obstacles were the subject of the Global GS1 Healthcare Conference held in Washington, DC on June 16. Crowley and other industry experts note that a barcode system would be necessary in order to track devices from the point of manufacture to delivery to the client. The myriad medical devices from artificial hips, knees, and cardiac defibrillators would have to be tracked from the time of creation to their eventual implantation in a human patient. The tracking would continue as long as the patient used the medical device.
Even for layperson, this is indeed a daunting task. Yet, it’s crucially important in order to ensure the safety of the consumer. Let’s hope the FDA perseveres in this task.

Medtronic’s Payment to Doctor Underscores Ethics Dilemna

The fact that Medtronic Inc., a leading medical device manufacturer, paid Dr. Timothy Kuklo $800,000 over the past three years is not as disturbing as the fact that Kuklo falsified and exaggerated the benefits of the company’s Infuse bone graft in scientific medical journals. Making matters worse, Kuklo stands accused of forging the signatures of medical co-authors.
The ethical quandary in this case has real life implications for the rest of us. This isn’t some ivory tower academic falsifying reports to justify a bloated consulting salary. Kuklo’s conclusions and writings promote a product that doctors around the country will rely upon to heal and restore health. The false claims can actually end up injuring patients. The scientific community that publishes these medical journals also suffers collateral damage from Kuklo’s behavior.
Presently, Congress is holding hearings regarding medical device safety. They’re trying to determine whether the FDA needs more regulatory power. While they’re investigating this issue, they also need to establish some basic groundrules concerning scientific research and the remuneration of the researchers. It seems to me that a researcher whose task it is to research a drug or medical device can’t be compensated by that same drug company or medical device company. There’s an inherent conflict of interest. The payment naturally predisposes the researcher to look favorably upon the drug or medical device.
If medical journals, doctors, and the community at large are to place their confidence in this research, the research itself must be beyond reproach. These conflictual relationships have to stop. Perhaps the establishment of an independent funding source that is operated apart from the companies would work.

Lawmaker Calls Medical Device Safety System Broken

Rep. Frank Pallone (D-NJ) who chairse a House Energy and Commerce subcommittee, characterized the country’s oversight of medical devices “broken”. Citing FDA inaction and lack of appropriate response in some instances, Pallone is trying to determine is new federal legislation or more FDA oversight is necessary to fix the problem.
Pallone cited what many industry analysts have been saying for quite some time. The safety measures and quality control presently in place is inadequate and is not protecting the public from defective or unsafe medical devices.
Examples of such recent defective medical devices are numerous. We’ve been involved in some of these matters including the Stryker hip, Kugel Mesh, Zimmer Durom Hip, and the Medtronic Sprint Fidelis defibrillator leads. These cases represent a danger to the general public who rely on these products for their safety and health.
According to a Reuters report, “Cardiologist William Maisel, who heads the nonprofit
Medical Devices Safety Institute, said recent recalls of
defibrillator wires and other devices raised questions about
the FDA’s ability to identify safety problems promptly. “Additional consumer safeguards are needed. Only bydemanding more thorough, scientific device evaluations can theFDA hope to reestablish consumer confidence in its ability to protect the public’s health,” Maisel told a House of Representatives Energy and Commerce subcommittee.

Zicam Recall-Not

In response to the FDA warning letter concerning Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs, the company has stubbornly refused to recall the products in spite of the fact that the products have been associated with anosmia-a loss of the sense of smell. In those who’ve been injured by Zicam products, the loss of smell may be permanent. The company, Matrixx Initiatives, Inc. has already faced hundreds of lawsuits with many more anticipated after Zicam was suspended yesterday.
In a company press release issued hours after the FDA warning letter, company officials complained that the FDA issued the public health advisory before contacting the company. Isn’t that the purpose of the FDA? Isn’t it the mission of the FDA to protect consumers not shield a healthcare company from lawsuits?
Even at this early stage, it appears that the manufacturers of Zicam were well aware of the potential dangers of their product. Yet, they continue to market it as a healthy, homeopathic remedy to lessen the severity and duration of the common cold. Zicam was a best selling product for Matrixx and its suspension is sure to cause financial woes.
Yet, the important issue here is consumer safety not a company’s bottom line. The new, aggressive approach of the FDA in suspending sales of Zicam is laudable and a move in the right direction.

Zicam Recalled after FDA Warning Letter

Zicam Cold Remedy received a stern warning from the FDA after approximately 130 have lost their sense of smell. In the wake of the FDA warning letter, Matrix Initiatives, Inc. has voluntarily recalled the product.
Zicam Cold Remedy is an over the counter medicine that delivers medicine in nasal swabs. However, the swabs have been linked to nasal nerve damage resulting in the loss of the sense of smell.
Zicam Cold Remedy is considered by the FDA to belong to a small group of remedies knows as homeopathic.
The FDA issued a warning letter to Mattrix, the manufacturer of the zinc-based homeopathic Zicam Cold Remedy, but stopped short of issuing a recall of the product. However, due to the warning letter, the makers of Zicam will now have to submit safety and effectiveness data concerning Zicam to the FDA. Because of the dangers determined to be associated with Zicam, the manufacturer will now have to go through an FDA approval process.
Of course, a logical question to ask at this point is why does the designation “homeopathic” exempt Zicam and other similar products from FDA review and the approval process. As we’re seeing with so-called “natural” diet supplements, they can be as dangerous as defective prescription drugs. There is nothing about a homeopathic product that inherently makes them safe. They should be forced to undergo the same rigorous evaluation as other drug products PRIOR to coming to market.
The global market for homeopathic remedies is around $200 million but it’s growing. This market includes Nutraceutical International Corp. and Natural Health Supply.
On the Matrixx website, the company boasts that “no plaintiff has ever won a court case. . .” involving Zicam. The company has known for years about the potential harm caused by its homeopathic remedy Zicam and the loss of the sense of smell. Hundreds of lawsuits have been filed against the company. Yet, it takes an FDA warning letter to have the product removed from the market.

Zicam Cold Remedy Gets Strong FDA Warning

Zicam Cold Remedy received a stern warning from the FDA after approximately 130 have lost their sense of smell. In the wake of the FDA warning letter, Matrix Initiatives, Inc. has voluntarily recalled the product.
Zicam Cold Remedy is an over the counter medicine that delivers medicine in nasal swabs. However, the swabs have been linked to nasal nerve damage resulting in the loss of the sense of smell.
Zicam Cold Remedy is considered by the FDA to belong to a small group of remedies knows as homeopathic.
The FDA issued a warning letter to Mattrix, the manufacturer of the zinc-based homeopathic Zicam Cold Remedy, but stopped short of issuing a recall of the product. However, due to the warning letter, the makers of Zicam will now have to submit safety and effectiveness data concerning Zicam to the FDA. Because of the dangers determined to be associated with Zicam, the manufacturer will now have to go through an FDA approval process.
Of course, a logical question to ask at this point is why does the designation “homeopathic” exempt Zicam and other similar products from FDA review and the approval process. As we’re seeing with so-called “natural” diet supplements, they can be as dangerous as defective prescription drugs. There is nothing about a homeopathic product that inherently makes them safe. They should be forced to undergo the same rigorous evaluation as other drug products PRIOR to coming to market.
The global market for homeopathic remedies is around $200 million but it’s growing. This market includes Nutraceutical International Corp. and Natural Health Supply.
On the Matrixx website, the company boasts that “no plaintiff has ever won a court case. . .” involving Zicam. The company has known for years about the potential harm caused by its homeopathic remedy Zicam and the loss of the sense of smell. Hundreds of lawsuits have been filed against the company. Yet, it takes an FDA warning letter to have the product removed from the market.

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